Funded in part by Pfizer, Nestec
Effect of Vitamin D Supplementation, Omega-3 Fatty Acid Supplementation, or a Strength-Training Exercise Program on Clinical Outcomes in Older Adults: The DO-HEALTH Randomized Clinical Trial
Bischoff-Ferrari HA, Vellas B, Rizzoli R, Kressig RW, da Silva JAP, Blauth M, Felson DT, McCloskey EV, Watzl B, Hofbauer LC, Felsenberg D, Willett WC, Dawson-Hughes B, Manson JE, Siebert U, Theiler R, Staehelin HB, de Godoi Rezende Costa Molino C, Chocano-Bedoya PO, Abderhalden LA, Egli A, Kanis JA, Orav EJ, DO-HEALTH Research Group
JAMA · 290 citations
Review labels
Neutral facts our review recorded about how this study was done. They describe method, never whether we like the result.
How it was studied
- Design
- Randomized controlled trial (indexed by PubMed)
- Studied in
- People
- Main outcome
- Clinical events such as disease or death
Who paid for it
- Funding
- Industry funded
- Company
- Pfizer
- Company
- Nestec
- Government
- Medical Research Council
- Government
- National Institute of Arthritis and Musculoskeletal and Skin Diseases
- Government
- NIAMS NIH HHS
- Grants
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (P30 AR 072571); Medical Research Council (MR/P020941/1)
Based on 5 listed funder(s).
Publication
- Published
- 2020-11-10 · JAMA · vol. 324 · issue 18 · p. 1855
- Publisher
- American Medical Association
- Cited
- 352 citations · more than 100% of similar papers · 23.5× the field average
- Impact
- Top 10% most cited in its field
- References
- 48 works
- Access
- Free to read
- Research areas
- Vitamin D Research Studies · Bone health and osteoporosis research · Fatty Acid Research and Health
- Keywords
- Medicine, Placebo, Randomized controlled trial, Vitamin D and neurology, Vitamin, Physical therapy, Blood pressure, Statistical significance, Internal medicine
- MeSH
- humans, hypertension, cholecalciferol, fatty acids, omega-3, vitamins, treatment outcome, follow-up studies, double-blind method, cognition disorders, health status, immunity, physical fitness, dietary supplements, aged, aged, 80 and over, female, male, fractures, bone, resistance training
23 authors
From CH, FR, PT, AT, US, GB, DE, AU
- Heike Annette Bischoff-Ferrari · correspondingUniversity of Zurich; Triemli Hospital; University Hospital Zurich
- Bruno J. VellasUniversité Toulouse III - Paul Sabatier; Inserm; Université Fédérale de Toulouse Midi-Pyrénées
- René RizzoliUniversity Hospital of Geneva
- Reto Werner KressigUniversity of Basel; Felix Platter-Hospital
- José António Pereira da SilvaHospitais da Universidade de Coimbra; University of Coimbra
- Michael BlauthInnsbruck Medical University; Universität Innsbruck
Abstract
Importance
The benefits of vitamin D, omega-3 fatty acids, and exercise in disease prevention remain unclear.
Objective
To test whether vitamin D, omega-3s, and a strength-training exercise program, alone or in combination, improved 6 health outcomes among older adults.
Design, setting, and participants
Double-blind, placebo-controlled, 2 × 2 × 2 factorial randomized clinical trial among 2157 adults aged 70 years or older who had no major health events in the 5 years prior to enrollment and had sufficient mobility and good cognitive status. Patients were recruited between December 2012 and November 2014, and final follow-up was in November 2017.
Interventions
Participants were randomized to 3 years of intervention in 1 of the following 8 groups: 2000 IU/d of vitamin D3, 1 g/d of omega-3s, and a strength-training exercise program (n = 264); vitamin D3 and omega-3s (n = 265); vitamin D3 and exercise (n = 275); vitamin D3 alone (n = 272); omega-3s and exercise (n = 275); omega-3s alone (n = 269); exercise alone (n = 267); or placebo (n = 270).
Main outcomes and measures
The 6 primary outcomes were change in systolic and diastolic blood pressure (BP), Short Physical Performance Battery (SPPB), Montreal Cognitive Assessment (MoCA), and incidence rates (IRs) of nonvertebral fractures and infections over 3 years. Based on multiple comparisons of 6 primary end points, 99% confidence intervals are presented and P < .01 was required for statistical significance.
Results
Among 2157 randomized participants (mean age, 74.9 years; 61.7% women), 1900 (88%) completed the study. Median follow-up was 2.99 years. Overall, there were no statistically significant benefits of any intervention individually or in combination for the 6 end points at 3 years. For instance, the differences in mean change in systolic BP with vitamin D vs no vitamin D and with omega-3s vs no omega-3s were both -0.8 (99% CI, -2.1 to 0.5) mm Hg, with P < .13 and P < .11, respectively; the difference in mean change in diastolic BP with omega-3s vs no omega-3s was -0.5 (99% CI, -1.2 to 0.2) mm Hg; P = .06); and the difference in mean change in IR of infections with omega-3s vs no omega-3s was -0.13 (99% CI, -0.23 to -0.03), with an IR ratio of 0.89 (99% CI, 0.78-1.01; P = .02). No effects were found on the outcomes of SPPB, MoCA, and incidence of nonvertebral fractures). A total of 25 deaths were reported, with similar numbers in all treatment groups.
Conclusions and relevance
Among adults without major comorbidities aged 70 years or older, treatment with vitamin D3, omega-3s, or a strength-training exercise program did not result in statistically significant differences in improvement in systolic or diastolic blood pressure, nonvertebral fractures, physical performance, infection rates, or cognitive function. These findings do not support the effectiveness of these 3 interventions for these clinical outcomes.
Trial registration
ClinicalTrials.gov Identifier: NCT01745263.
Abstract via Europe PMC. Copyright remains with the authors or publisher.
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